药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2026/01/06 – 2026/01/12

Period
2026/01/06 to 2026/01/12, 7 days inclusive
Data as of
2026/11/05 06:00
Cached records
94,245 acceptance records, 11,689 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
461
Drugs with new generic filings (by drug name, de-duplicated)
79
Accepted this week, now under review
172

DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.

Drug and company names link to detail pages; sign in to view them.

New acceptances this week

By application type and drug type

461filings, 117 of them generic

By application type

Application typeFilings
Supplement175
New drug134
Generic117
Import21
Unspecified11
Import re-registration3

By drug type

Drug typeFilings
Chemical drug284
治疗用生物制品94
TCM74
预防用生物制品6
Biologic3

DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.

Most new generic filings, by drug

79 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1非奈利酮片5371
2磷酸奥司他韦胶囊4242
3美阿沙坦钾片4233
4布立西坦片4116
5布瑞哌唑片3131
6糠酸莫米松乳膏3116
7左炔诺孕酮片225
8戊酸雌二醇片227
9瑞卢戈利片222
10艾托格列净片2211

DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.

Most new acceptances, by company

261 companies with new acceptances; top 10 listed

DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.

Under-review list changes

Compared across this platform's snapshots of the under-review list

Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.

DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.

Class 3 and new-drug acceptances

184 this week

AcceptedDrugApplicants
2026/01/12New drug · Class 1 注射用SKB103CXSL2600069 四川科伦博泰生物医药股份有限公司
2026/01/12New drug · Class 1 BG-A3004注射液CXSL2600068 广州百济神州生物制药有限公司
2026/01/12New drug · Class 1 注射用华卟啉钠CXHS2600017 上海光声制药股份有限公司
2026/01/10Import · Class 1 奥氟格列隆片JXHS2600014 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/01/10Import · Class 1 奥氟格列隆片JXHS2600013 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/01/10Import · Class 1 奥氟格列隆片JXHS2600012 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/01/10Import · Class 1 奥氟格列隆片JXHS2600011 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/01/10Import · Class 1 奥氟格列隆片JXHS2600010 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/01/10Import · Class 1 奥氟格列隆片JXHS2600009 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/01/10Import · Class 1 奥氟格列隆片JXHS2600008 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/01/10Import · Class 1 奥氟格列隆片JXHS2600007 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/01/10Import · Class 1 奥氟格列隆片JXHS2600006 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/01/10Import · Class 1 奥氟格列隆片JXHS2600005 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/01/10Import · Class 1 奥氟格列隆片JXHS2600004 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/01/10Import · Class 1 奥氟格列隆片JXHS2600003 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/01/10Generic · Class 3 复方匹可硫酸钠口服溶液CYHS2600137 南京康川济医药科技有限公司; 瑞华(中山)制药有限公司
2026/01/10Generic · Class 3 雷美替胺片CYHS2600136 南京正大天晴制药有限公司
2026/01/10Generic · Class 3 盐酸精氨酸注射液CYHS2600130 海南广升誉制药有限公司; 海南爱科制药有限公司
2026/01/10Generic · Class 3 尿素[13C]片呼气试验药盒CYHL2600006 湖南华纳大药厂股份有限公司
2026/01/10Generic · Class 3 瑞卢戈利片CYHL2600005 杭州民生药业股份有限公司
2026/01/10New drug · Class 1.1 固表通窍颗粒CXZL2600004 九华华源药业股份有限公司
2026/01/10New drug · Class 2.2 恩沃利单抗注射液CXSS2600007 四川思路康瑞药业有限公司; 江苏康宁杰瑞生物制药有限公司
2026/01/10New drug · Class 1.2 YKYY025注射液CXSL2600066 北京悦康科创医药科技股份有限公司; 杭州天龙药业有限公司
2026/01/10New drug · Class 1 AK117注射液CXSL2600065 中山康方生物医药有限公司
2026/01/10New drug · Class 1 AK117注射液CXSL2600064 中山康方生物医药有限公司
2026/01/10New drug · Class 1 AK109注射液CXSL2600063 康融东方(广东)医药有限公司
2026/01/10New drug · Class 1 注射用AK138D1CXSL2600062 中山康方生物医药有限公司
2026/01/10New drug · Class 1 注射用AK146D1CXSL2600061 中山康方生物医药有限公司
2026/01/10New drug · Class 3.4 人凝血酶CXSL2600060 广东双林生物制药有限公司
2026/01/10New drug · Class 1 TQB2922注射液CXSL2600059 正大天晴药业集团南京顺欣制药有限公司

154 more not listed (at most 30 rows).

DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.

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